Ambulatory spinal unloading method and apparatus

ABSTRACT

An ambulatory spinal unloading method and apparatus are implemented to achieve a desired minimum level of residual cushioning in response to a biasing force applied to the associated apparatus tensioning and/or compression mechanism(s). The ambulatory spinal unloading apparatus may further include a treatment system to provide desired levels of nerve and/or muscle stimulation in addition to hot and/or cold elements to provide further therapeutic effects as desired or necessary.

CLAIM TO PRIORITY OF PROVISIONAL APPLICATION

This application is a Continuation of U.S. patent application Ser. No.11/094,862, which is a Continuation-in-Part of U.S. patent applicationSer. No. 11/035,485, and further claims priority under 35 U.S.C. §119(e) (1) of U.S. Provisional Application Ser. No. 60/640,479.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to methods and apparatus that mayemploy electrical stimulation and/or hot/cold compresses, among otherthings, for alleviating pain due to abnormalities associated with, butnot limited to, body weight, internal organs, muscles and various spinalinfractions, and more particularly, to a method and apparatus forimplementing ambulatory spinal unloading.

2. Description of the Prior Art

Traction has long been the treatment of choice for alleviating pain dueto certain bodily abnormalities associated with, but not necessarilylimited to, internal organs, muscles, body and various spinalinfractions. U.S. Pat. No. 6,749,579 B1, entitled Traction Garment,issued Jun. 15, 2004 to Schroder, for example, discloses a nonstationaryor ambulatory traction garment that includes a plurality of tensionspreaders to provide injury-specific traction while restricting unwantedand potentially injurious motions.

Other U.S. patents, e.g. U.S. Pat. No. 5,704,904, issued Jan. 6, 1998 toDunfee; U.S. Pat. No. 5,724,993, issued Mar. 10, 1998; and U.S. Pat. No.5,950,628, issued Sep. 14, 1999 to Dunfee, the inventor of the presentinvention, each disclose use of an ambulatory, wearable support forapplying an extending force or traction to a portion of the humananatomy while being worn. These wearable supports employ a plurality ofextender sets having at least one selectively inflatable bladder.

U.S. Pat. No. 6,689,082 B2, and U.S. Pat. No. 6,776,767 B2, issued Feb.10, 2004 and Aug. 17, 2004 respectively to Reinecke et al., disclose anambulatory traction device that employs one or more lifting mechanismsconfigured to apply a decompressive force to a portion of a user's bodywhen positioned around the user's body.

A flexible fluidic force generator capable of applying both an extending(traction) force and a compressive force to a portion of the humananatomy while being worn is disclosed in U.S. Pat. No. 6,237,602 B1,entitled Flexible Fluidic Force Generator, issued May 29, 2001, toNickels et al.

While all of the devices described herein above have provided someadvances in the field of ambulatory traction devices, they remaindeficient in providing an effective residual spinal cushioning or spinalunloading condition, in the absence of a biased tensioning and/orcompressive force.

In view of the foregoing, it would be desirable and advantageous in theart to provide a method and apparatus for implementing ambulatory spinalunloading, even in the absence of a biased tensile or traction force tothose areas to relieve a portion of the compressive load on the spine toalleviate pain, and to optionally allow proper healing of bodilyinjuries. It would be further advantageous if the method and apparatuscould employ embedded electrodes to deliver electrical stimulation inlike fashion to known transcutaneous electrical nerve stimulation (TENS)that are readily available in the market place.

SUMMARY OF THE INVENTION

The present invention is directed to an ambulatory spinal unloadingmethod and apparatus that are implemented by defining a set of desiredhuman characteristics and/or parameters and then implementing anambulatory traction and cushioning apparatus structure based on the setof human characteristics/parameters to achieve a desired minimum levelof residual cushioning, upon deactivating the bias applied to theassociated apparatus tensioning and/or compression mechanism(s). Themethod and apparatus eliminate the absolute necessity for trial anderror testing by an end user, and further allow the ambulatory spinalunloading apparatus to be optimized to the desired humancharacteristic(s) and/or parameter(s). A substantial benefit provided bythis optimized apparatus is the avoidance of further inadvertentinjuries experienced by an end user due to undesirable trial and errortechniques such as those generally associated with apparatus that arealready known in the related art. Further, the optimized apparatus willallow an end user in many instances, to wear the apparatus for muchlonger periods of time than that achievable using known apparatus,without experiencing fatigue. This feature is particularly desirablesince it will decrease the level of discomfort generally associated withbodily injuries and thereby benefit a user who is wearing the optimizedspinal unloading apparatus. This method and apparatus thereforeimportantly allows a doctor to prescribe both a tension time period anda compression (non-biased) time period, to yield long term spinalrelief. A period of therapeutic electrical stimulation and/or hot/coldpack treatment is desirably prescribed concurrent with for subsequent tothe foregoing tension and compression time periods. The desired humancharacteristics and/or parameters may include, but are not limited to,height, weight, percent of body fat, a plurality of desiredcircumferential measurements, relative location of human anomaly(s),period of time in traction, amount or percent of body weight, desiredtraction level(s), length of time and percent of body weight to besubjected to spinal cushioning apparatus, a desired therapeuticapplication and so on.

In one aspect of the invention, an ambulatory spinal unloading apparatusabsorbs undesirable pressure caused by degenerative disc or nervefaucets, using both compression and expansion features provided via alifter assembly or mechanism.

In another aspect of the invention, an ambulatory spinal unloadingapparatus eliminates the necessity to develop time tables and datanecessary to formulate correct orthotic belts.

In yet another aspect of the invention, an ambulatory spinal unloadingapparatus provides flexible stabilizing effects to yield a desired levelof user comfort, even in the absence of activation or biasing of anylifter mechanism(s).

One embodiment of the invention provides a spinal unloading apparatushaving an upper or thoracic belt and a lower or lumbar belt in which thethoracic belt and the lumbar belt are separated via a single posteriorlifting mechanism. The single posterior lifting mechanism can beformulated, for example, via a single fluidic i.e. piston drivenpneumatic chamber in combination with a residual cushioning mechanismsuch as one or more gel-filled chambers to provide a desired level ofresidual cushioning upon the removal of fluidic pressure from thefluidic chamber. The single posterior lifting mechanism may optionallybe formulated via a mechanically actuated or electro-mechanicallyactuated device. The mechanically actuated device can be implemented,for example, via a spring structure that may be compressed and releasedvia one or more cam mechanisms. The electro-mechanically actuated devicecan be implemented, for example, via one or more stepper motorsconfigured to selectively adjust one or more extension means, i.e. rods.The electro-mechanically actuated device could optionally beimplemented, for example, via one or more motor actuated worm gears,belts, or pulley mechanisms, turning one or more threaded extensionrods. Regardless, the electro-mechanically actuated device(s) are energyefficient such that the desired lifting effect(s) can be achieved usinga portable battery pack that may be rechargeable or a portable powerpack that may, for example, receive its primary source of power from anautomotive accessory outlet. The thoracic belt and the lumbar belt aresufficiently rigid such that a desired spinal lifting effect can beachieved from the single posterior lifting mechanism. Further, thethoracic belt and the lumbar belt may each comprise one or more internalfluidic chambers strategically located to provide a desired level ofuser comfort and to prevent restrictive binding of the user's thoracicregion. These internal fluidic chambers can be replaced instead by oneor more pockets configured to receive hot and/or cold compresses.Additional lifting and/or residual cushioning mechanisms can optionallybe positioned between the thoracic and lumbar belts at desired locationsto provide a desired lifting and/or residual cushioning effect to theuser's anterior region subsequent to attaching the spinal unloadingapparatus. These additional lifting and/or residual cushioningmechanisms most preferably are implemented via non-fluidic meanswhenever the posterior lifting mechanism employs fluidic means, andimplemented via fluidic means whenever the posterior lifting mechanismemploys non-fluidic means, such that the spinal unloading apparatusnever employs more than a single fluidic lifting mechanism.

The orthotic belts comprising the spinal unloading apparatus canoptionally be implemented with integral electrodes that are positionedsuch that a desired level of muscular and/or nerve stimulation can beachieved while a user is wearing the spinal unloading apparatus. Mostpreferably, these integral electrodes are activated/energized via theportable battery pack or power pack that also provides power to theelectro-mechanical lifting mechanism(s). Such muscle and/or nervestimulation can accelerate the spinal healing process due to a reductionin the level of discomfort/pain associated with spinal unloading thatmay be experienced by the end user.

The upper, or thoracic, belt, which may have the shape of a vest orshirt, may further have shoulder straps configured to ease user fittingand removal.

BRIEF DESCRIPTION OF THE DRAWINGS

Other aspects, features and advantages of the present invention will bereadily appreciated as the invention becomes better understood byreference to the following detailed description when considered inconnection with the accompanying drawing figures wherein:

FIG. 1 illustrates a spinal unloading apparatus having a substantiallyrigid upper thoracic belt, a substantially rigid lower lumbar belt and asingle posterior lifting mechanism;

FIG. 2 a illustrates a piston actuated fluidic lifting device thatemploys a residual cushioning spring in accordance with one embodimentof the present invention;

FIG. 2 b illustrates a piston actuated fluidic lifting device thatemploys gel-filled cushion chambers in accordance with one embodiment ofthe present invention;

FIG. 2 c illustrates a piston actuated fluidic lifting device thatemploys an electric motor driving a worm gear turning a threaded rod inaccordance with one embodiment of the present invention;

FIG. 3 illustrates another ambulatory spinal unloading apparatuscomprising an upper orthotic belt and a lower orthotic belt joined via asingle cable/slide assembly posterior lifter mechanism;

FIG. 4 a illustrates a mechanical lifter mechanism that employs astabilizer spring and a set of mechanical adjusters suitable to form thelifting portion of an ambulatory spinal unloading apparatus such as thatshown, for example, in FIG. 1;

FIG. 4 b illustrates another mechanical lifter mechanism that employs aset of stabilizer springs and a set of mechanical adjusters suitable toform the lifting portion of an ambulatory spinal unloading apparatussuch as that shown, for example, in FIG. 1;

FIG. 5 illustrates an orthotic traction vest comprising an upper beltand a lower belt joined via a single posterior traction lifter and onepair of anterior traction lifters;

FIG. 6 illustrates an electro-mechanical lifter assembly that issuitable to implement any of the lifter mechanisms depicted in FIGS. 1and 5;

FIG. 7 a is a side view illustrating a combination lumbar support andhot/cold element having embedded foam pads;

FIG. 7 b is a front view illustrating the combination lumbar support andhot/cold element having embedded foam pads shown in FIG. 7 a;

FIG. 8 illustrates an orthotic traction vest comprising an upper beltand a lower belt joined via a single cable/slide type posterior tractionlifter mechanism;

FIG. 9 illustrates a thoracic belt assembly having one or more embeddedair bags configured to prevent restrictive binding of a user's thoracicregion;

FIG. 10 illustrates a thoracic belt assembly having a plurality ofspinal unloading features, therapeutic features and stimulation featuresaccording to one embodiment of the present invention;

FIG. 11 illustrates an orthotic traction vest comprising an upper beltand a lower belt joined via a single rack and pinion type posteriortraction lifter mechanism; and

FIG. 12 illustrates an orthotic traction vest comprising an upper beltand a lower belt joined via a single posterior lifter mechanism in whichthe upper and lower belts comprise electrical stimulation contactelectrodes.

While the above-identified drawing figures set forth particularembodiments, other embodiments of the present invention are alsocontemplated, as noted in the discussion. In all cases, this disclosurepresents illustrated embodiments of the present invention by way ofrepresentation and not limitation. Numerous other modifications andembodiments can be devised by those skilled in the art which fall withinthe scope and spirit of the principles of this invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

An ambulatory spinal unloading method and apparatus are implemented, asstated herein before, by defining a set of desired human characteristicsand/or parameters and then implementing an ambulatory traction andcushioning apparatus structure based on the set of humancharacteristics/parameters to achieve a desire minimum level of residualcushioning, upon deactivating the associated apparatus biasingmechanism(s). These desired human characteristics/parameters mayinclude, but are not limited to, height, weight, percent of body fat, aplurality of desired circumferential measurements, relative location ofhuman anomaly/anomalies, period of time in traction, amount or percentof body weight to be subjected to spinal cushioning apparatus, desiredtraction levels, and so on. The ambulatory spinal unloading apparatus isconfigured to absorb an intermittent and/or unexpected shock and/orvibration using compression and expansion features provided via a lifterassembly such as described herein below with reference to FIGS. 1-12.The ambulatory spinal unloading apparatus may optionally employelectrical nerve and/or muscle stimulation through desired electrodesand may further employ hot and/or cold compresses.

Looking first at FIG. 1, a simple ambulatory spinal unloading apparatus100 can be seen to include two orthotic belts 102, 104 joined via asingle posterior lifter assembly 106 formulated as described in furtherdetail herein below. Lifter assembly 106 can be seen attached to belts102, 104 via a plurality of attachment elements 108. i.e. rivets. Thepresent invention is not so limited however, and it shall be understoodthat a plurality of posterior and/or anterior liftermechanisms/assemblies 106 could just as easily be implemented to providethe desired compression and expansion features and to sustain tractionin accordance with the principles of the present invention.

Advantages and features of the present invention will become morereadily apparent in view of the known art that generally employs aplurality of lifters/lifter assemblies which result in undesirable rigidtraction in the absence of lifter mechanism biasing/activation. Withcontinued reference now to FIG. 1, the upper (thoracic) belt 102 ispositioned about a user's thoracic region; while the lower (lumbar) belt104 is positioned below a user's thoracic region, and is most preferablytightened securely to provide a substantially fixed operating point forthe apparatus 100. When the lift mechanism 106 is activated or biased,the apparatus 100 will provide a traction effect. When the liftmechanism 106 is deactivated or unbiased, the apparatus 100 will providethe desired compression and expansion features via the residualcushioning apparatus 110 discussed in further detail herein below. Thesingle posterior lift mechanism 106 can be implemented via a fluidicchamber, such as, for example, an air chamber configured to actuate apiston rod formulated to selectively control separation or distancebetween the upper and lower belts 102, 104. Lift mechanism 106 canoptionally be implemented via a simple pneumatic chamber without the useof a piston rod, such that greater lifting if achieved with greater airpressure, and such that lifting is reduced with decreasing air pressure.Such fluidic devices are well known in the art and so will not bediscussed in further detail herein. The present invention is not solimited however; and while known fluidic devices are devoid of residualcushioning effects when the fluidic device is not pressurized, such isnot the case in the absence of pressure (bias) when using the fluidicdevice(s) in accordance with the principles described herein.

FIG. 2 a, for example, illustrates a piston actuated fluidic liftingdevice 200 that employs a residual cushioning spring 202 and that issuitable for use as the posterior lifting mechanism 106 shown in FIG. 1.Cushioning spring 202 serves to provide a desired level of residualcushioning for an end user in the event fluidic pressure is partially orcompletely removed from the fluidic chamber. Fluidic lifting device 200can be seen to employ a fluidic, i.e. air, chamber having a fluidicinput port 254 into which a fluidic, i.e. air pressure can be directed.The fluidic pressure serves to move a piston that is sealed via one ormore o-ring seals 203.

FIG. 2 b illustrates a piston actuated fluidic lifting device 250 thatemploys gel-filled cushion chambers 252 and that is also suitable foruse as the posterior lifting mechanism 106 shown in FIG. 1. Thesechambers 252 are compressed when the fluidic lifting device 250 ispressurized via fluidic port 254, to provide the maximum lifting effect.When the fluidic lifting device 250 is de-pressurized, the gel-filledchamber(s) 252 expand to provide a desired residual cushioning effect.The amount and type of gel that is employed to fill the chamber(s) 252is selected using well-known engineering principles to provide thedesired cushioning effect(s). A percent of a person's body weight may beused by a physician, for example, to determine a criteria associatedwith desired resistive characteristics to establish the amount and typeof gel.

FIG. 2 c illustrates a piston actuated fluidic lifting device 280 thatemploys an electric worm gear motor 282 driving a worm gear turning ascrew threaded rod 284, and that is also suitable for use as theposterior lifting mechanism shown in FIG. 1. Residual cushioning in thisinstance is provided solely via a single lower gel-filled chamber. Thegel compresses as the rod 284 is extended, and expands as the rod 284retracts.

The embodiments described herein with reference to the figures werefound by the present inventors to eliminate the necessity to developtime tables and data necessary to formulate acceptable known orthoticbelts. Modern ambulatory traction apparatus and devices, for example,are most often designed and manufactured using rigid and narrowsemi-circular belts which results in too much pressure on any one pointof a person's body, and also do not allow enough material area todissipate large amounts of a person's body weight.

It is noteworthy that, unlike known ambulatory spinal traction/supportdevices, structures implemented in accordance with the principlesdescribed herein make use of mathematical computations associated withhuman characteristics and/or parameters that may include, for example,but are not limited to, percent of body fat to determine structuralrelated data such as strength, size and length of lift required. Thistechnique then allows for a “one size fits all” lifter structure thatmay, for example, utilize a single pneumatic biasing mechanism.

Unlike common modern ambulatory traction devices that use various rigidlifter(s) such as assemblies that employ pneumatic pistons, which whenunbiased, maintain a rigid device around a person's thoracic regionwhich makes the device difficult to wear when not biased, theembodiments described herein deliver a desired residual amount ofcushioning, as stated herein before, upon deactivation of thelifter(s)/lifter assemblies. Values associated with percent of residualcushioning will, of course, depend upon the specific abnormality, but,as discovered by the present inventors, could be as low as about 5percent of a person's body weight.

Upper and lower orthotic belts 102, 104, as stated herein before, canoptionally be formulated to selectively integrate fluidic chambers suchas air pockets that function to eliminate restrictive binding of auser's thoracic region when the assembly 100 is worn by the user. Theseair pockets could instead be replaced with pockets configured toselectively receive hot and/or cold packs. Orthotic belts 102, 104,further may be formulated with a desired quantity of accessory pocketsconfigured to accept inflatable cushions or gel-filled packs that mayoptionally be temperature controlled to provide a residual cushioningeffect in combination with a cold or hot compress effect upon insertionof the gel-filled pack(s) into one or more pockets.

FIG. 3 illustrates another ambulatory spinal unloading apparatus 300comprising an upper thoracic belt 102 and a lower lumbar belt 104 joinedvia a single posterior lifter mechanism. The Lifter mechanism mostpreferably can be a single fluidic device that provides the user with aflexible fluidic force capable of applying both an extending (traction)force and a compressive force to a portion of the human anatomy whilebeing worn. Alternatively, the lifter mechanism can be non-fluidic suchthat any traction and/or compressive force can be implemented withoutuse of any fluidic pressure. The lifter mechanism, could for example, beimplemented via one or more mechanical devices or electro-mechanicaldevices such as those discussed in further detail herein below.Importantly, ambulatory spinal unloading apparatus 300 comprises no morethan a single fluidic lifter mechanism and operates differently thanknown ambulatory traction and orthotic structures, such that, when usedin association with an upper thoracic belt 102, provides a desiredamount of residual cushioning or spinal unloading, even when the liftermechanism is unbiased or inactivated.

With continued reference now to FIG. 3, a lifter mechanism can be seento include a slide mechanism 308 attached via a plurality of attachmentelements 310 to the upper and lower belts 102, 104. Pulleys 312, 314 areattached to the upper and lower belts 102, 104 respectively. Anotherpulley mechanism 316 is attached to a drive motor assembly 320 thatoperates a cable assembly 322 to separate the upper and lower belts 102,104 via slide mechanism 308 as the cable assembly 322 is retracted viapulleys 312, 314 and pulley mechanism 316. A return spring 330 operatesto move the belts 102, 104 closer together via slide mechanism 308 asthe cable assembly tension is reduced via drive motor assembly 320. Themotor assembly 320 is powered via a portable power pack 340 and caninclude batteries that may be rechargeable. A control mechanism 350 canbe seen attached to the lower belt 104; and most preferably can be usedby the end user to activate and deactivate drive motor assembly 320 asdesired to provide a desired spinal unloading effect.

The cushioned lifter mechanism(s), assemblies and devices describedherein with reference to the figures can employ numerous structuralmaterials, such as, but not limited to, metals, plastics, gels andrubbers, to provide a lifter embodiment having both compressive andexpansion characteristics such that the inventive ambulatory spinalunloading method and apparatus will provide a flexible stabilizingeffect that yields a desired level of user comfort, even when thecushioned lifter mechanism(s) is not activated or biased. Althoughparticular embodiments are described herein using fluidic devices,mechanical devices, and electro-mechanical devices, the presentinvention is not so limited, and it shall be understood that the desiredresidual cushioning could just as easily be implemented using particularmaterials that are commonly employed by those skilled in the mechanicalengineering arts and versed in the structural, shock and vibration artsto implement elastomeric damping structures. Such materials may include,but are not limited to, gels, natural rubbers, synthetic resins such aspolyvinyl chlorides, polyurethanes, polyamides, polystyrenes,copolymerized polyvinyl chlorides, polyolefin synthetic rubbers, as wellas urethanes, EPDM, styrene-butadiene rubbers, nitrites, isoprene,chloroprenes, polypropylene, and silicones.

FIG. 4 a illustrates a mechanical lifter mechanism 400 that employs astabilizer spring 402 and a set of mechanical adjusters 404, 406suitable to form the lifting portion of an ambulatory spinal unloadingapparatus such as that shown, for example, in FIG. 1. Rotation ofeither/or mechanical adjuster 404 and mechanical adjustor 406 serves toselectively compress and/or decompress stabilizer spring 402, such thateven when the mechanical adjusters 404, 406 are rotated to remove allcompressive effects, the stabilizer spring 402 will provide a residualcushioning effect. The amount of residual cushioning effect will varywith the rotation of the mechanical adjusters 404, 406.

FIG. 4 b illustrates another mechanical lifter mechanism 450 thatemploys a set of stabilizer springs 452, 454, 456 and a set ofmechanical adjusters 404, 406 suitable to form the lifting portion of anambulatory spinal unloading apparatus such as that shown, for example,in FIG. 1. Biasing of the lifter mechanism(s) 400, 450 is implementedvia rotation of one or more of the mechanical adjusters 404, 406. Properdesign of the mechanical adjusters 404, 406 will allow for either abiased or unbiased condition. When unbiased, only the stabilizerspring(s) 402, 452, 454, 456 solely will provide the desired residualcushioning effect. The stabilizer springs 402, 452, 454, 456 can be amore conventional steel spring structure, or may, for example, beformulated using any of the elastomeric damping materials referencedherein before.

Moving now to FIG. 5, an orthotic traction vest 500 is depictedcomprising an upper belt 102 and a lower belt 104 joined via a singleposterior traction lifter 106 and one pair of anterior traction lifters502, 504. The single posterior traction lifter 106, as stated hereinbefore, can be any type of biased lifter mechanism, fluidic ornon-fluidic, that provides a desired level of user comfort and residualcushioning determined via the human body characteristics and/orparameters as discussed herein before. Lifter mechanism 106, can be, forexample, a piston driven air chamber positioned between one or moregel-filled chambers or pockets, such as described herein before. Thisdesired residual cushioning can optionally be implemented via fluidicchambers, e.g. air pockets integrated into one or more of the orthoticbelts 102, 104 such that any restrictive binding of a user's thoracicregion is also substantially eliminated, even when lifter mechanisms106, 502, 504 are not activated or biased. The present invention is notso limited, and it shall be understood that lifter mechanisms 106, 502,504 can be implemented via mechanical and/or electro-mechanical means solong as the desired residual cushioning and spinal unloadingcharacteristics are achieved according to the principles of theinvention discussed herein.

FIG. 6 illustrates an electro-mechanical lifter assembly 600 that issuitable to implement any of the lifter mechanisms 106, 502, 504. Lifterassembly 600 can be seen to include one or more worm gear drive motors602 that operate to extend and retract one or more threaded rods 604.The present invention is not so limited however, and it shall beunderstood that drive motor 602 could just as well be an electricstepper motor that operates to selectively extend or reduce the distancebetween orthotic belts 102, 104 via a requisite shaft or rod assembly604. Lifter assembly 600 could further be implemented instead by usingbelt and pulley techniques discussed herein before, of which numeroussuitable motors, pulleys, belts and cables are familiar to those skilledin the art. Power to the electric motor(s) 602 is provided via aportable power or battery pack 606 that may be rechargeable. Since theelectro-mechanical lifter assembly 600 presents a rigid lifting effectto the end user, assembly 600 is combined with one or more residualcushioning spring mechanisms 610 such that a desired residual cushioningeffect is achieved whenever the motor 602 fully retracts the screwthread or solid rod(s) 604.

FIGS. 7 a and 7 b illustrate side and front views respectively for anassembly 700 including a combination lumbar support and hot/cold element702 having embedded foam pads 704. The assembly 700 exterior isfabricated using a suitable fabric 703 that snaps together at its endsvia snap devices 706, and that includes a zippered opening 708 toremovably receive one or more foam pads 704 and a desired hot/coldelement. Assembly 700 can be seen to be implemented with integratedelectrodes 710 strategically placed about the fabric 703 region. Theseorthotic electrodes 710 may be energized via the electric motor powerpack 606 shown in FIG. 6, and are positioned to generate a desired levelof muscle and/or nerve stimulation to the user's lumbar region. Thebenefits and advantages of providing such muscle and/or nervestimulation are well documented in the art, and so a discussionregarding such benefits and advantages will not be set forth herein inorder to provide clarity and to promote brevity. The present inventors,however, are not aware of any structures or applications in which suchmuscle and/or nerve stimulation electrodes are integrated into theorthotic belt assembly portion or any other portion of an ambulatorytraction device or spinal unloading device. In this manner, the orthoticassembly 100, 500 operates to provide spinal unloading and residualcushioning with a substantially reduced level of pain to the end user,in contradistinction to known orthotic assemblies in which the end useroften experiences substantial levels of discomfort and pain duringactivation of the orthotic assembly. In one application, assembly 700may be inserted into a belt 104 pocket, such as discussed herein before,that is implemented to removably receive such assemblies and/or devices.

FIG. 8 illustrates an orthotic traction vest 800 comprising an upperbelt 102 and a lower belt 104 joined via a single cable/slide typeposterior traction lifter mechanism 802. Lifter mechanism 802 can beseen to be attached to upper and lower belts 102, 104 via suitableattachment elements 804 such as, but not limited to, rivets and thelike. Upper belt 102 can be seen to further include a pulley assembly806 that operates in response to a cable pulley drive motor 814 to movethe cable/slide type lifter mechanism 802. Cable/slide type liftermechanism 802 can be seen to be anchored within a chamber 808 thatcomprises a portion of the lower belt 104. Residual spring cushions 810,812 are strategically placed at each end of the lifter mechanism 802such that a desired level of residual cushioning is provided wheneverthe cable/slide assembly is in its minimal belt separation position,i.e. whenever tension is completely released on cable 816 via drivemotor 814. Drive motor 814 is powered via a portable power or batterypack 818 that may be rechargeable. A control unit 820 is attached tolower belt 104 that can be user operated to control the amount ofseparation between upper and lower belts 102, 104 via cable/slide typelifter mechanism 802 in response to drive motor 814.

FIG. 9 illustrates a thoracic belt assembly 900 having one or moreembedded air bags 902 configured to prevent restrictive binding of auser's thoracic region. An air pump 904 or other suitable fluidicbiasing means is provided to supply the requisite fluidic chamberpressure. These air bags 902 could easily be replaced instead withhot/cold compresses, gel-filled packs, cushions, or other types ofelements to deliver a desired therapeutic effect to an end user.Thoracic belt 102 could instead employ one or more pockets or openingthat are configured to removably receive any of the elements discussedherein above.

FIG. 10 illustrates a thoracic belt assembly 1000 having a plurality ofspinal unloading features, therapeutic features and stimulation featuresaccording to one embodiment of the present invention. Belt assembly 1000can be seen to include upper (thoracic) belt 102 and lower (lumbar) belt104. A single posterior lift mechanism 1002 is attached to upper andlower belts 102, 104 via suitable attachment elements 1004. A worm geardrive motor 1006 comprises a lower portion of the lift mechanism 1002;while a threaded screw receiver mechanism 1008 comprises an upperportion of the lift mechanism 1002. A screw rod or threaded rod 1010 isrotated via drive motor 1006 to turn the screw rod 1010 within receivermechanism 1008 to selectively increase or decrease the distance betweenupper and lower belts 102, 104. Upper belt 102 can be seen to furtherinclude thoracic contact electrodes such as described herein before, andthat operate to stimulate certain thoracic nerves and/or muscles asdesired. Lower belt 104 can likewise be seen to further include lumbarcontact electrodes the operate to stimulate certain lumbar nerves and/ormuscles as desired. Residual cushioning springs 1012, such as discussedherein before, are strategically positioned at each end of liftmechanism 1002 to provide a desired level of residual cushioningwhenever the lift mechanism 1002 is in its minimal belt separationposition. Drive motor 1006 is most preferably powered via an AC and/orDC portable power or battery pack 1014 that may be rechargeable. Controlcircuitry 1016 is integrated into lower belt 104 and is accessible viauser controls 1018 to control separation distance between upper andlower belts 102, 104 as well as strategic nerve and/or musclestimulation. A recording apparatus 1020, such as, but not limited to, aread/write E-prom, is provided to record strategic traction, spinalunloading, stimulation, and/or therapeutic parameters provided to an enduser during the period of time thoracic belt assembly 1000 is worn bythe end user. With continued reference now to FIG. 10, upper belt 102can be seen to also include a pair of shoulder straps 1022 that may beadjustable to comfortably fit the end user and strategically positionthe thoracic belt assembly 1000 to optimize the desired traction,unloading, stimulation, and/or therapeutic effects. Thoracic beltassembly 1000 can be seen to also include a lumbar pad assembly 1024having stimulation contact electrodes and other features such as thatdescribed herein before with reference to FIGS. 7 a and 7 b. Snaps 1026or other suitable means are employed to attach lumbar pad assembly 1024to the upper belt 104.

FIG. 11 illustrates an orthotic traction vest 1100 comprising an upperbelt 102 and a lower belt 104 joined via a single rack and pinion typeposterior traction lifter mechanism 1102. Upper and lower portions oflifter mechanism 1102 are attached to upper and lower belts 102, 104 viasuitable attachment elements. The present inventors found rivets to be asuitable attachment element in many applications. Upper portion oflifter mechanism 1102 can be seen to include a first gear drive motor1104; while lower portion of lifter mechanism 1102 can be seen toinclude a second gear drive motor 1106. Upper and lower portions oflifter mechanism can be seen to further include springs that operate toprovide a residual cushioning effect whenever the lifter mechanism 1002is in its minimal belt separation position. The present invention is notso limited however, and it shall be understood that this embodiment orany embodiment of the present invention can include any other type ofresidual cushioning apparatus as discussed or referenced herein beforeto provide a residual cushioning effect in accordance with theprinciples set forth herein. Extension rod 1108 has teeth along itsentire length that allow each drive motor 1104, 1106 to selectively movethe rod 1108 in a desired direction to control the distance betweenupper and lower belts 102, 104. A portable power/battery pack 1110 isprovided to provide power to the drive motors 1104, 1106. Portablepower/battery pack 1110 may be an AC and/or DC powered device asdesired. An end user operated control circuit 1112 is included to allowan end user to selectively activate each drive motor 1004, 1006individually or together as desired to achieve a desired spinalunloading effect to the end user.

FIG. 12 illustrates an orthotic traction vest 1200 comprising an upperbelt 102 and a lower belt 104 joined via a single posterior liftermechanism 1202 in which the upper and lower belts 102, 104 compriseelectrical stimulation contact electrodes 1204, such as discussed hereinbefore, to provide a desired level of strategic thoracic and/or lumbarnerve and/or muscle stimulation. Those skilled in the therapeutic artswill readily appreciate that the number and placement of such electrodeswill vary and depend upon the therapeutic effect(s) desired from thestimulation when combined with the desired level of spinal unloadingprovided via orthotic traction vest 1200.

In summary explanation, an ambulatory spinal unloading method andapparatus are implemented by defining a set of desired humancharacteristics and/or parameters and then implementing an ambulatorytraction and cushioning apparatus structure based on the set of humancharacteristics/parameters to achieve a desired minimum level ofresidual cushioning, even in the absence of any bias applied to theassociated apparatus tensioning and/or compression mechanism(s). Thistechnique eliminates the need for trial and error testing by an enduser, and further allows the ambulatory spinal unloading apparatus to beoptimized to the desired human characteristic(s) and/or parameter(s). Asubstantial benefit provided by this optimized apparatus is theavoidance of further inadvertent injuries experienced by an end user dueto undesirable trial and error methods associated with apparatus that isalready known in the related art. Further, the optimized apparatus willallow an end user in many instances, to wear the apparatus for muchlonger periods of time than that achievable using known apparatus,without experiencing fatigue. This feature is particularly desirablesince it will enhance the healing time associated with bodily injuriesthat will benefit from wearing the optimized spinal unloading apparatus,especially when the spinal unloading is combined with therapeuticelectrical nerve and/or muscle stimulation and/or application of hotand/or cold compresses. The desired human characteristics and/orparameters may include, but are not limited to, height, weight, percentof body fat, a plurality of desired circumferential measurements,relative location of human anomaly(s), period of time in traction,amount or percent of body weight, desired traction level(s), length oftime and percent of body weight to be subjected to spinal cushioningapparatus and/or therapeutic treatment, and so on.

1. An ambulatory spinal unloading apparatus configured to provide adesired amount of traction force to a spine of a patient and to absorban intermittent and/or unexpected shock and/or vibration, with thetraction force provided via a plurality of lifter assemblies,comprising: an upper orthotic belt; a lower orthotic belt; a residualcushioning device; and the plurality of lifter assemblies; wherein theplurality of lifter assemblies each independently expands or retracts tocontrol distance between the orthotic belts to provide the tractionforce to a spine of a patient, and each of the lifter assemblies furthercomprises a residual cushioning device that independently provides adesired residual cushioning effect by compression of a spring and/ordamper to thereby absorb an intermittent and/or unexpected shock and/orvibration, wherein the spring and/or damper is effective to provide theresidual cushioning for the lifting assembly in a deactivated state. 2.The apparatus of claim 1 with the lifter assemblies each comprising aworm gear turning a threaded rod or a piston actuated fluidic liftingdevice.
 3. The apparatus of claim 2, with at least one of the lifterassemblies comprising a piston actuated fluidic lifting device.
 4. Theapparatus of claim 3 wherein the piston actuated fluidic lifting devicecomprises a pneumatically operated piston.
 5. The apparatus of claim 3wherein the piston actuated fluidic lifting device comprises a pair ofpistons connected by a piston rod, and with each piston fitting apneumatic cylinder.
 6. The apparatus of claim 5 further comprising agel-filled chamber that provides the residual cushioning.
 7. The spinalunloading apparatus according to claim 1, wherein at least one orthoticbelt comprises integrated electrodes selectively positioned to provide adesired level of muscle or nerve stimulation in response to a desiredelectrical bias.
 8. The apparatus of claim 1 further comprising aplurality of contact electrodes to deliver transcutaneous electricalnerve stimulation.
 9. The apparatus of claim 1 wherein the upperorthotic belt and/or the lower orthotic belt comprises a plurality ofcontact electrodes to deliver transcutaneous electrical nervestimulation.
 10. The apparatus of claim 1 further comprising a lumbarpad assembly that comprises a plurality of contact electrodes to delivertranscutaneous electrical nerve stimulation.
 11. The spinal unloadingapparatus according to claim 1, wherein the residual cushioning devicecomprises a gel-filled chamber.
 12. The spinal unloading apparatusaccording to claim 1, wherein the residual cushioning device comprisesthe spring.
 13. The spinal unloading apparatus according to claim 1,wherein the residual cushioning device comprises the damper.
 14. Thespinal unloading apparatus according to claim 1, wherein each of theplurality of lifter assemblies comprises no more than one fluidicchamber.
 15. The spinal unloading apparatus according to claim 1,wherein the plurality of lifter assemblies each comprise at least oneelectric motor configured in combination with a mechanical extensionshaft assembly to selectively control the distance.
 16. The spinalunloading apparatus according to claim 15, wherein the mechanicalextension shaft assembly comprises at least one element selected fromthe group consisting of belts, pulleys, cables, threaded shafts, andgears.
 17. The spinal unloading apparatus according to claim 1, furthercomprising a lumbar support apparatus selectively positioned between theupper and lower belts.
 18. The spinal unloading apparatus according toclaim 17, wherein the lumbar support comprises a hot pack.
 19. Thespinal unloading apparatus according to claim 1, further comprising arecording apparatus operational to selectively record desiredinformation associated with at least one parameter selected from thelist consisting of traction, spinal unloading, stimulation, and/ortherapeutic parameters.
 20. A method of spinal unloading comprising:providing an ambulatory spinal unloading apparatus that comprises afirst orthotic belt, a second orthotic belt, and a plurality of lifterassemblies configured to selectively vary a distance between theorthotic belts a residual cushioning device that provides a desiredresidual cushioning effect achieved by compression of a spring and/ordamper to thereby absorb an intermittent and/or unexpected shock and/orvibration for the threaded rod or for the piston actuated fluidiclifting device in a deactivated state.
 21. The method of claim 20further comprising providing transcutaneous electrical nerve stimulationthrough a plurality of contact electrodes.
 22. The method of claim 20further comprising providing transcutaneous electrical nerve stimulationthrough a plurality of contact electrodes located on the upper belt, thelower belt, and/or a lumbar belt.
 23. The method of claim 22 furthercomprising providing a heat source in combination with thetranscutaneous electrical nerve stimulation.
 24. The method of claim 23comprising providing a pocket for a hot pack at or near the plurality ofcontact electrodes.
 25. The method of claim 20, with at least one of thelifter assemblies comprising a piston actuated fluidic lifting devicethat comprises a pneumatically operated piston.
 26. The method of claim20 wherein the piston actuated fluidic lifting device comprises a pairof pistons connected by a piston rod, with each piston fitting apneumatic cylinder, and further comprising supplying a gas to one of thecylinders for moving the piston rod.